Regulatory Affairs Officer

Job highlights

• Years of Experience: Minimum 5 Years in Medical Device/ Pharma/ Life science

Qualification:
M Sc Life Science/ BTech Medical / B Pharm/ M Pharm.

• Minimum of 23 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation

Job description
This is a full-time on-site role for a Regulatory Specialist.

The Regulatory Specialist will be responsible for ensuring regulatory compliance, staying up-to-date with regulatory requirements, and utilizing analytical skills to identify potential issues.

The Regulatory Specialist will also be responsible for communicating with regulatory agencies and providing regulatory affairs support to other teams.

Years of Experience:
Minimum 5 Years in Medical Device/ Pharma/ Life science

Qualification:
M Sc Life Science/ BTech Medical / B Pharm/ M Pharm

Minimum Requirements:

• Minimum of 23 years of experience in regulatory affairs Healthcare industry, with specific experience in USFDA / 510K submission and MDSAP Audit preparation

.
- understanding of cGMP and US FDA guidelines.

• Ability to effectively present information to management and other groups
• Experience in preparing and managing regulatory dossiers, including DMFs, INDs, MAAs, and other regulatory submissions.
• Excellent understanding of pharmaceutical product development processes, manufacturing, and quality control.
• Strong attention to detail and accuracy in documentation and data management.
• Effective communication and interpersonal skills, with the ability to collaborate with crossfunctional teams and interact with regulatory authorities.
• Proficiency in using regulatory affairs software, document management systems, and Microsoft Office Suite.
• Ability to multitask, prioritize workload, and meet tight deadlines in a fastpaced and dynamic environment.
• Knowledge of international regulatory requirements and experience with Health Canada/ Brazil/ Japan/ USFDA/ Australia regulatory submissions is a plus.
• Certification or training in USFDA/ Other Regulatory affairs is preferred

Roles and Responsibilities

• Prepares eCTD filings for submission to the US Food and Drug Administration (US FDA) and other global regulatory agencies.
• Review and interpret regulatory guidelines and communicate updates and changes to internal stakeholders.
• Coordinate with crossfunctional teams, including R&D quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation.
• Collaborate with regulatory authorities and agencies to address queries, provide additional information, and facilitate dossier review processes.
• Stay updated with evolving regulatory requirements and industry trends related to USFDA.
• Prepares all product listing, facility registration, product label updates, and facility identification for submission to the US FDA.
• Support and coordinate for MDSAP / ISO 13485 / QMS Audits, Internal Audits, and Complaints and CAPA process.
• Responsible for verifying specification of excipients, active, finished product and packaging material, and all required documents.
• Creates, maintains and facilitates Sponsor Approval of project documents related to study startup, including the Essential Document Templates, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms.
• Creates, maintains and facilitates Client Approval of project status reports.
• Prepares and presents a projectspecific overview to Clinical Operations, Investigator Grant Management and Global Regulatory Affairs staff regarding start up deliverables, timelines and processes.
• Oversees site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites are needed, and escalates delays, where applicable.
• Oversees the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In
• House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions are developed, collected, reviewed and tracked according to the processes and timelines agreed upon on the project.
• Collaborates with the Global Regulatory Affairs Lead (GRAL) assigned to the project to ensure Ministry of Health (MoH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines.
• Collaborates with the GRAL and Clinical Team Manager (CTM) assigned to the project to ensure importation, exportation, insurance, labeling of Investigational Product (IP) and any other country requirements are met to ensure the timely activation of trial sites.
• Oversees Local Ethics Committee (IEC) and other local authority submissions and approvals for their country/region or the project as applicable.
• During Start-Up, works with GRAL/ LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where

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